Biomarker discovery & validation: Shifting research away from silos & towards collaborative endeavours

A fundamental challenge in developing drugs for certain diseases is that there is relatively little known about the pathophysiology or the natural history of the disease. Moreover, there are only a small number of experienced clinical investigators worldwide and little scientific literature published. The consequence of this is that there is uncertainty about the disease mechanisms, lack of adequate pre-clinical models and incomplete knowledge of potential biomarkers.

Commercializing biomarkers directly can be difficult. With recent legal cases like Myriad, there is added unpredictability as to what can be patented in relation to biomarkers making investments risky. Many organizations stand to benefit in new biomarkers however only a few can make the investments solely by themselves.

Encouraging organizations to collaborate rather than compete can significantly accelerate the discovery and validation of many more valuable biomarkers. An effective way of enabling this is via the creation of consortia. In simple terms think of these as a coalition of organizations working together both in their self-interests and towards a common goal.

Precompetitive collaboration where organizations share information on early stages of research that benefits all, is a potential driver for innovation and increased productivity. Several biomarker consortia  are being developed in the mission to create research ecosystems and platforms to address various unmet clinical needs and to help industry both discover and validate potential biomarkers that could be valuable in the development of new diagnostic tests as well as more effective and safer treatments. Nevertheless, developing consortia comes with its own risks and rewards (Table 1)

Table 1: Pros and Cons of forming consortia

Table 1: Pros and Cons of forming consortia

The “cons” in consortium building can be handled with better management in defined structure and governance arrangements.

One such management structure is  ‘lead partner’ consortium. In this model, organisations could come together to form a consortium and nominate a ‘lead organisation’ which the others agree to work through. The consortium would usually be led by a joint steering group including members of each organisation. A consortium agreement would be put in place among members of the consortium which would set out their legal rights and obligations. All partners would be allocated areas of work based on specialism and capacity. This way the organizations are clear on their contributions and less internal competitions.

The lead organisation would apply for contract funding on behalf of consortium members and manage the contract, distributing funds to other members via subcontracting arrangements for particular services or outputs. The benefits are they are able to make use of existing contract management and accountable body systems and also due to the established reputation of the lead organisation in particular, this model may be perceived as less ‘risky’ by funders. The “lead” management model reduces on management cost and aims on effective decision making and productivity.

One of the best examples of a good management model and a completed project of the cross-company precompetitive collaboration is a study that was conducted under the Metabolic Disorder Steering Committee of the Biomarker Consortium (a public–private partnership managed by the Foundation for the National Institutes of Health (FNIH)). Here the goal was to analyze the clinical trial data from four pharmaceutical companies in relation to adiponectin, a potential biomarker to predict HbA1c response in patients with type 2 diabetes  At the time it was unclear whether this was a valid biomarker due to lack of clinical relevance data and complexity in developing assays. The data shared by the companies was beneficial in determining the quality of the biomarker and the evidence supported the potential use of adiponectin for glucose tolerance.

It’s promising to see consortium projects ongoing in a range of clinical areas including metabolic disorders, Alzheimer’s disease, lung cancer, and lymphoma. Nevertheless, scaling consortia to a wider range of clinical areas could dramatically help accelerate the availability of new diagnostics and treatments which could be improving and saving precious lives.

What are your thoughts on the formation of more biomarker consortia to accelerate the discovery and validation of biomarkers? Would you participate?

Please share comments below.

References

  1. J A, Wagner et al. “The Biomarkers Consortium: Practice and Pitfalls of Open-Source Precompetitive Collaboration.” (Clinical Pharmacology and Therapeutics 2010) 87: 539:542.
  2. http://consortiasupport.org.uk/wp-content/uploads/2012/01/Pros-and-Cons-of-forming-Consortium-handout.pdf
  3. http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231115.htm
  4. http://www.communitymatters.org.uk/content/563/What-is-a-consortium-and-how-does-it-differ-from-a-partnership

Supriya Shekar

Co-founder at Medbiomarkers
Supriya Shekar is a Co-Founder of Medbiomarkers, a company accelerating the translation of biomarker research via providing data and software solutions and building biomarker related consortia. Supriya has over 8 years of experience in developing molecular diagnostics including IVD assays and companion diagnostics in the areas of infectious diseases and oncology. Most recently she worked in the Companion Diagnostics division of Novartis.